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EP2666500B1 - Dispositif inhalateur avec mécanisme d'avancement de blister amélioré - Google Patents

Dispositif inhalateur avec mécanisme d'avancement de blister amélioré Download PDF

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Publication number
EP2666500B1
EP2666500B1 EP13169227.9A EP13169227A EP2666500B1 EP 2666500 B1 EP2666500 B1 EP 2666500B1 EP 13169227 A EP13169227 A EP 13169227A EP 2666500 B1 EP2666500 B1 EP 2666500B1
Authority
EP
European Patent Office
Prior art keywords
trigger
blister
gear
actuator lever
present
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP13169227.9A
Other languages
German (de)
English (en)
Other versions
EP2666500A1 (fr
Inventor
Zafer Toksöz
Ümit Cifter
Ali TÜRKYILMAZ
Onur Mutlu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arven Ilac Sanayi ve Ticaret AS
Original Assignee
Arven Ilac Sanayi ve Ticaret AS
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Publication date
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Publication of EP2666500A1 publication Critical patent/EP2666500A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A61M15/0026—Hinged caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043—Non-destructive separation of the package, e.g. peeling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0051—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged on a tape, e.g. strips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0053—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type or way of disposal
    • A61M15/0055—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type or way of disposal the used dosages being coiled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

Definitions

  • the present invention relates to a device for administering dry powder inhalation drugs.
  • the present invention particularly relates to improvements made in the blister advancement mechanism of dry powder inhaler devices.
  • inhalation devices for administering inhalation drugs nowadays. These devices are basically classified into two groups, i.e. metered dose inhalers and dry powder inhalers. These types of devices are structurally provided with basic components such as an actuator, counter, body, lid, lock, etc. Additionally, powder inhalation drugs are kept in carriers such as blisters, capsules, etc. Blisters are composed of two basic parts, a main layer provided with cavities carrying the drug, and a strippable protective layer.
  • Such devices comprise an outer body and a lid provided thereon, an inner body disposed in the outer body, a blister strip disposed in the inner body, a lower holder comprising this strip in a rolled manner, and a gear and gear set aligned in an interconnected and functionally-compatible manner to store the main layer comprising cavities after the blister strip is moved and separated into its layers.
  • a lever or trigger mechanism is developed to actuate this mechanism.
  • the linear motion performed by a trigger is converted into a circular motion by means of a gear.
  • This trigger is slid into a slot provided in the device body to provide an linear/axial motion, such that the force resulting from this motion is transmitted to a blister advancement mechanism in the device by means of a gear with which the trigger is in engagement.
  • the gears serving to transmit and translate this drive are overloaded.
  • using extra gears gives rise to losses in force transmission. Eliminating this loss, in turn, requires more force to be applied.
  • Another drawback is that slackness do occur between the extra gear and the contact surfaces. In result, this slackness and the exertion of extra force brings about a more important problem, which causes the gears in the mechanism to break down or wear out.
  • inhaler devices require certain training and practice.
  • development of inhaler devices always occurs in the form of practical systems, providing the patients with improved convenience of use. Selecting the proper device for a respective patient is also an important issue. Many criteria, such as a patient's cognitive and physical efficiency, ease of use, safety and price, etc. are considered while a device is selected.
  • US 4 733 797 discloses a dosage sealing, monitoring and dispensing assembly including a mounting receptacle and one or more cartridges removably connected to the receptacle. Each cartridge has sealed therewithin a fresh, supply of dosage units carried in moisture impervious shells on a flexible, segmented strip.
  • WO 01/66061 discloses an apparatus to dose medicaments and control taking in the medicaments, which apparatus consists of a storage unit to store tablets or capsules, a dosing unit and a counter.
  • the characteristic feature of the apparatus is that the medicaments are packed in a medicament tape and stored in the storage unit and cylinders furthering said medicament tape are attached to the storage unit and the said cylinders are mechanically coupled with a manual driving unit.
  • US 2004/050385 discloses an inhaler for delivery of a dry powder medicament, the inhaler comprising a breath sensor for sensing the breath of a patient; means for transporting the medicament to a delivery position; and electro-mechanical coupling means for actuating said transport means, wherein said coupling means is directly or indirectly responsive to the breath sensor.
  • US 2009/283095 A1 discloses an inhaler comprising: a body; at least one cover element that is movable between a closed position and an open position; individual reservoirs formed on a reservoir substrate; movable support means that receive said reservoir substrate and that are displaceable between a non-dispensing position and a dispensing position; and an indicator device for indicating doses that have been dispensed or that remain to be dispensed.
  • US 5 590 645 discloses an inhalation device is described for use with a medicament pack in which at least one container for medicament in powder form is defined between two sheets peelably secured to one another.
  • the device comprises means for peeling the sheets apart at an opening station to open the container; and an outlet, communicating with the opened container, through which a user can inhale medicament in powder form from the opened container.
  • US 2002/032409 relates to a dispenser for dischargeable media, preferably containing at least one active pharmaceutical substance and packed in portioned manner in storage chambers of a storage means, as well as a conveying device for the supply of the storage means.
  • the present invention relates to an improved inhaler device for use with dry powder inhaling purposes, eliminating all aforesaid problems and bringing additional advantages to the relevant prior art. Accordingly, the main object of the present invention is to provide a dry powder inhaler device, which can be operated at a desired accuracy, provide the peeling off of the blister to be used, and perform this process faultlessly as compared to precedent devices.
  • Another object of the present invention is to reduce the force which needs to be exerted to the trigger of the device to operate the same.
  • a further object of the present invention is to avoid any breaking and wearing-out of device components by decreasing the force applied to the surface of the gears and the mechanism thereof.
  • a blister advancement mechanism for a dry powder inhaler device comprising an outer body and a trigger disposed to axially displace in this outer body
  • said blister advancement mechanism being structured to advance a blister strip having drug carrying cavities and to release the drug from the next drug carrying cavity of the blister strip and further comprising a transmission gear and a set of interconnected gears.
  • the blister advancement mechanism comprises at least one actuator lever, which is coupled to the trigger on one side, and to the circular transmission gear on the other side, and is provided with teeth on at least a portion thereof, to transmit a force exerted to the trigger to the gear set and to convert the linear/axial motion of the trigger into circular motion.
  • the actuator lever and the trigger comprise a groove and a pivot connection pin to enable the actuator lever to perform a rotational motion.
  • the teeth on the actuator lever are disposed on a circular surface.
  • the teeth on the actuator lever are disposed on a linear surface.
  • the actuator lever and the trigger are fixed to each other to enable the actuator lever to perform an linear/axial motion.
  • the outer body (1) of the inhaler device (6) according to the present invention as representatively shown in figures 1 , 9a , 9b , 11a, 11b, 11c, 11d is obtained by assembling two complementary parts together.
  • the inner periphery of said parts comprises fastening tabs to fasten these parts together, as well as grooves and pins enabling to place the coupled guide gear and transmission gear (19, 5) and the coupled gear set (16, 17, 18) winding the blister cover in the outer body (1).
  • the upper part of the body is provided with a mouthpiece having a drug outlet opening.
  • the lower part of the body is provided with a trigger (2) which can be slid into the body.
  • An inner body (11) is disposed in the interior of the outer body (1) to receive a blister, as illustrated representatively in Figure 8 .
  • This single-piece body (11) comprises lower, left and right middle and upper holders (12, 13, 14, 15), along with recessed surfaces and fastening tabs.
  • An unused blister (4) is stored in the lower holder (12), this strip-formed blister (4) being extended along intermediate channels and subsequently separated into two parts, i.e. the main layer and the protective layer, by means of the mechanism.
  • the main layer of which the tip is fixed to the second additional gear (21) is held in the left middle holder (13) of the second additional gear (21).
  • the tip of the cover layer is fixed to a pin provided on the middle winding gear (17).
  • a trigger (2) slid into a lower part of said outer body (1).
  • the trigger (2) is capable to axially displace in the interior of the body (1).
  • a surface provided on the exterior of the trigger (2) to which a user exerts force to push in the trigger has an inwardly curved structure to provide ease of use.
  • a spring (22) is disposed between the trigger (2) and the inner surface (1) of the outer body, the spring being structured to become compressed (i.e. loaded) when the trigger (2) is pushed into the body (1).
  • the spring (22) is a helical spring.
  • an actuator lever (8) is provided, which is coupled to the trigger (2) on one side, and to the circular transmission gear (5) on the other side, and is provided with teeth (7) on at least a portion thereof.
  • This lever (8) comprises a groove (9).
  • On the trigger (2) is provided a connection pin (10). When this pin (10) is introduced into the groove (9), both a connection is provided, and the actuator lever (8) is enabled to move back and forth and to rotate in a free manner.
  • the actuator lever (8) is either fixed to a whole gear, or a part of the tip of the lever (8) is formed into a circular or linear gear.
  • the guide gear (19) of which a representative embodiment is detailed in Figure 9a moves on a single direction and provides only the advancement of the blister.
  • the transmission gear (5) disposed below the guide gear, in turn, is capable to rotate forward and backward.
  • the operation of the device according to the present invention is as follows. Following the opening of the lid, a force is exerted by the user to the grip surface of the trigger (2). Then the trigger (2) is driven or slid into the interior of the body (1).
  • the actuator lever (8) which is in connection with the trigger (2) transmits this drive to the transmission gear (5).
  • the transmission gear (5) transmits this drive to the guide gear (19) and to the first and second additional gears (20, 21). Thereafter, the transmission gear and the lower winding gear of the blister lid (18) and the upper and middle winding gears of the blister lid (16, 17) which are disposed on the lower winding gear of the blister lid (18) are set in rotational motion on opposite sides.
  • the winding gears of the blister lid (18, 16, 17) are rotated clockwise, whereas the transmission gear and the guide gear (5, 19) are rotated counterclockwise.
  • the blister (4) in connection with these gears is advanced in the channels of the inner body (11), is passed through and pealed off between the gear sets, and the drug in the cavity is released.
  • the main layer of the blister, now separated into two parts, is rolled in the left middle holder (13), whereas the protective layer is wound onto the upper gear of the blister lid (16).
  • a retaining recess provided on the trigger (2) is coupled to a locking clips lug provided just over itself, resulting in the administration of a single dose of drug. Keeping this slide-in action until the locking position is achieved guarantees the complete peeling-off of the blister and ensures the accurate administration of the required dosage amount. As a result of this locking effect, the trigger (2) becomes retained and it remains out-of-use for a short period of time. This slide-in action also causes the spring (22) to become compressed between the inner surface of the body (1) and the trigger (2).
  • the device according to the present invention can be operated by a simple single push action of the user.
  • the device (6) is wound up automatically and is restored for the next use.
  • the actuator lever (8) is fixed to the trigger (2). With this embodiment, sliding the trigger forth and back makes the transmission gear (5) rotate forward and backward. It is further possible to operate the device according to this alternative embodiment.
  • an inhaler device is obtained with the embodiment disclosed above, wherein this device is extremely accurate, safely operated, the force required to operate the device and exerted to the components of the mechanism is reduced, and wherein cost and size advantages are provided.
  • an actuator lever (8) is used which is provided with teeth (7) on at least a part thereof to ensure the advantages given above.
  • the linear motion of the trigger is the sliding in-out motion of the trigger on any direction, including those on the x and y axes. This direction is determined according to the design of the device.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (3)

  1. Un mécanisme d'avancement de blister pour un inhalateur de poudre sèche (6) comprenant une gâchette (2) disposée de manière à se déplacer axialement dans un corps extérieur de l'inhalateur sous l'effet de la force exercée par l'utilisateur, un engrenage de transmission et un ensemble de roues dentées interconnectées pour l'avancement d'un blister à l'intérieur de l'inhalateur et ledit mécanisme d'avancement de blister étant structuré pour faire avancer une bande de blister (4) ayant des cavités porteuses de médicament (3) et pour faire sortir le médicament à libérer hors desdites cavités porteuses de médicament de la bande de blister, caractérisé en ce qu'il comprend en outre :
    - au moins un levier d'actionnement (8) couplé à ladite gâchette (2) d'un côté par une tige de connexion de pivot (10) de la gâchette introduite dans une rainure (9) du levier d'actionnement (8), et audit engrenage de transmission circulaire (5) de l'autre côté, de telle sorte que le levier d'actionnement (8) soit capable d'exécuter un mouvement de rotation et que ledit levier d'actionnement (8) soit au moins partiellement pourvu de dents (7) pour transmettre une force exercée sur la gâchette (2) à un train d'engrenages et pour convertir le mouvement linéaire/axial de la gâchette en un mouvement circulaire.
  2. Le mécanisme d'avancement de blister selon la revendication 1, dans lequel les dents (7) sont disposées sur le levier d'actionnement (8) sur une surface circulaire.
  3. Le mécanisme d'avancement de blister selon l'une quelconque des revendications précédentes, dans lequel les dents (7) sont disposées sur le levier d'actionnement (8) sur une surface linéaire.
EP13169227.9A 2012-05-25 2013-05-24 Dispositif inhalateur avec mécanisme d'avancement de blister amélioré Active EP2666500B1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
TR201206167 2012-05-25
TR201301562 2013-02-08
TR201301847 2013-02-15
TR201301950 2013-02-19

Publications (2)

Publication Number Publication Date
EP2666500A1 EP2666500A1 (fr) 2013-11-27
EP2666500B1 true EP2666500B1 (fr) 2016-09-07

Family

ID=48794178

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13169227.9A Active EP2666500B1 (fr) 2012-05-25 2013-05-24 Dispositif inhalateur avec mécanisme d'avancement de blister amélioré

Country Status (2)

Country Link
EP (1) EP2666500B1 (fr)
WO (1) WO2013176639A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD855792S1 (en) * 2013-01-30 2019-08-06 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Inhaler device
USD745138S1 (en) * 2013-01-30 2015-12-08 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Member of an inhaler device
USD737424S1 (en) * 2013-01-30 2015-08-25 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Button of an inhaler device

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4733797A (en) * 1986-09-22 1988-03-29 Haber Terry M Dosage sealing, monitoring and dispensing assembly
GB9004781D0 (en) * 1990-03-02 1990-04-25 Glaxo Group Ltd Device
DE10011120A1 (de) * 2000-03-09 2001-09-13 Pfeiffer Erich Gmbh & Co Kg Spender für Medien
US20030102324A1 (en) * 2000-03-09 2003-06-05 Miklos Illyes Apparatus for dosage of medicaments
US20040050385A1 (en) * 2000-10-20 2004-03-18 Bonney Stanley George Inhaler
AU2007210177C1 (en) * 2006-01-31 2012-11-01 Oriel Therapeutics, Inc. Dry powder inhalers having spiral travel paths, unit dose microcartridges with dry powder, related devices and methods
FR2904297B1 (fr) * 2006-07-25 2008-10-10 Valois Sas Dispositif de distribution de produit fluide.
PL2239003T3 (pl) 2009-03-30 2015-04-30 Arven Ilac Sanayi Ve Ticaret As Licznik dla urządzenia inhalacyjnego suchego proszku
ATE549052T1 (de) 2009-03-30 2012-03-15 Sanovel Ilac Sanayi Ve Ticaret As Trockenpulverinhalatorvorrichtung

Also Published As

Publication number Publication date
WO2013176639A1 (fr) 2013-11-28
EP2666500A1 (fr) 2013-11-27

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